Expedited Interval Tubal Scheduling: An Intervention to Increase Rates of Completion of Tubal Sterilization Within 6 Months Post-partum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Completion of Tubal Sterilization
研究概览
简要总结
Over 50% of all pregnancies that occur in the US are unintended, and unintended pregnancy is detrimental to maternal and child health. Tubal sterilization may be performed immediately following a delivery, or as an interval procedure remote from pregnancy. Many women request sterilization to follow delivery, but it is frequently not completed during the peri-partum hospitalization. Women who are denied an immediate post-partum tubal are generally candidates to complete the procedure as an interval surgery within a few months of delivery, but few do so. Women who request tubal sterilization and do not receive it are at highest risk for a rapid repeat pregnancy, with as many as 46% having an unintended pregnancy within 1 year.
The standard care at many institutions for a patient denied tubal sterilization during hospitalization is to offer a short term contraceptive and instruct the patient to follow up for the standard post-partum outpatient visit in 4-6 weeks. If the patient still desires tubal sterilization at that time, the surgical procedure will be scheduled. No-show rates for post-partum care are high at about 50%-60%, and therefore, many patients are never scheduled for their surgery. If the process of scheduling interval tubal sterilization surgery could be expedited, rates of completion could be improved.
详细描述
Identification of potential participants: On admission to the hospital for labor, all women will be asked if they were planning to tie their tubes after their delivery. Women who requested tubal ligation and have not received this on post-partum day one, and who are not anticipated to have it completed on post-partum days 2 or 3, and who did not have a contraceptive device (IUD or Nexplanon) placed that the time of delivery will be identified from hospital service lists.
Enrollment: All patients meeting inclusion criteria will be approached by study personnel and asked about whether sterilization is their preferred contraceptive method. If the potential participant still expresses a desire for permanent sterilization, the potential participant will be offered enrollment in the study. The study will be described, and the expected preferred method of sterilization identified. The participant will sign informed consent.
Allocation Concealment: A randomization sequence will be developed with a computerized number generator, and will generate participant assignments in a 1:1 ration with randomly permuted block sizes of 4, 6, and 8. A person not involved with study enrollment will place cards with participant assignments in a series of sequentially numbered, sealed opaque sealed envelopes. These envelopes will be stored on the post partum floor, and after a patient completes the informed consent, the next sequential envelope will be opened.
Randomization: The potential candidate will be randomized by opening of the next sequentially numbered sealed envelope. The assignment will be noted and disclosed. The assignment will be noted in the study chart, and the card with the assignment will be stored with the chart.
Study protocol following randomization:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •>21 years of age (required for sterilization by Medicaid rules)
- •Requested sterilization either during antepartum care or at time of delivery
- •Did not have sterilization performed on L&D for any reason
- •Confirmed desire for sterilization during post-partum hospitalization (has not changed mind)
- •Has commercial or Medicaid insurance that will allow for outpatient surgery (including pregnancy-related emergency Medicaid)
- •Consent to phone follow-up calls regarding study in the 6 months following enrollment
排除标准
- •<21 years of age
- •Unable to provide informed consent
- •Not a candidate for a laparoscopic or hysteroscopic procedure for any medical reason
- •Uninsured or undocumented status that would prevent scheduling of an outpatient surgery
- •Unable to provide reasonably reliable contact information
结局指标
主要结局
Completion of Tubal Sterilization
时间窗: 6 months
Proportion of participants who complete requested tubal ligation surgery within 6 months of their delivery.
次要结局
- Participant Satisfaction(6 months)
- Repeat pregnancy Rates(6 months)